BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6974175 · Received October 24, 2017

    Report

    Report Number
    3007981285-2017-31224
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 24, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (200-336 MG/DL) AND THE CAUSE WAS NOT KNOWN. CORRECTION BOLUSES AND INSULIN INJECTIONS WERE USED TO ADDRESS THE BG LEVEL. AT TIMES THE CUSTOMER REQUIRED ASSISTANCE FROM THE SCHOOL NURSE WITH THE TREATMENT OF THE HIGH BG. A PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUES WERE IDENTIFIED. REPORTEDLY, THE CUSTOMER DISCUSSED THE HIGH BG EVENT WITH A CLINICAL DIABETES SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752013 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention INFUSION SET: T:90, INSULIN: NOVOLOG